Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

Ulcerative Colitis Clinical Trial

Official title:

A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326209
• Other study ID #: MPUC3005
• Status: Completed
• Phase: Phase 3
• Start date: December 22, 2005
• Est. completion date: May 5, 2008

Study information

• Verified date: October 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets [MP]) in participants with ulcerative colitis currently in remission.

Description:

This is a Phase 3, multicenter, open-label, treatment extension study evaluating the long-term safety and tolerability of eMG given once daily (QD) in participants who successfully participated in a double-blind lead-in study (MPUC3003 [NCT00744016 ] or MPUC3004 [NCT00767728 ]) or new participants who are currently in remission from symptoms of ulcerative colitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: May 5, 2008
• Est. primary completion date: May 5, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. An Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent is signed and dated prior to any study-related activities.

2. Participant has successfully participated in a previous MP clinical study per investigator's discretion with successful participation minimally defined as compliant with study-related procedures and study drug dosing schedule in the previous study and did not discontinue from the previous study due to study drug-related AE(s) or if new participants:

a. Participant is a male or,

If the participant is female, she is eligible to enter if she is of:

Non-childbearing potential (that is; physiologically incapable of becoming pregnant, including any female who has undergone sterilization [hysterectomy or bilateral tubal ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses); or childbearing potential, has a negative serum pregnancy test at screen and, if heterosexually active, agrees to one of the following:

i) Double barrier method of contraception, specifically, use of a condom and spermicide, for 1 week prior to study drug administration, throughout the 6-month Treatment Phase, and the 2-week follow-up phase.

ii) Oral contraceptives administered for at least 2 monthly cycles prior to study drug administration during all 6 months of study drug administration and administered for 1 monthly cycle following completion of the study.

iii) An intrauterine device (IUD), inserted by a qualified clinician, with published data showing that the lowest expected failure rate is less than (<)1% per year (not all IUDs meet this criterion).

iv) Medroxyprogesterone acetate (DEPO-PROVERA) administered for a minimum of 1 monthly cycle prior to the study drug administration, during all 6 months of study drug administration, and administered for 1 monthly cycle following study completion. Norelgestromin/ ethinyl estradiol transdermal system (Ortho Evra patch) administered for at least 2 monthly cycles prior to study drug administration and administered for 2 monthly cycles following study completion.

v) Partner has undergone vasectomy and participant is in a monogamous relationship.

The investigator is responsible for determining whether the participant has adequate birth control for study participation.

b. Participant is greater than or equal to (=) 18 years of age. c. Participant has historically confirmed diagnosis (physician letter for newly/recently diagnosed and by medical records for previously diagnosed participants) of mild to moderate UC in remission for greater than (>) 1 month and <12 months.

d. Confirmed current remission defined as both: A screening rectal bleeding score of 0 as described in the Disease Activity Index (DAI) (Sutherland Index) where 0 = None A screening sigmoidoscopy score of 0 to 1 for mucosal appearance as described in the (Sutherland Index where 0 = intact mucosa with preserved or distorted vessels and 1 = Erythema, decreased vascular pattern, granularity, no mucosal hemorrhage.

3. Participant and investigator consider there is the potential for benefit to the participant with MP treatment.

4. Participant is capable and willing to comply with all study procedures.

Exclusion Criteria:

1. Participant has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.

If a new participant, the following additional exclusion criteria will apply:

2. Participant has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.

3. Participant has an abnormal clinical lab result which in the opinion of the investigator is significant enough to prevent participant's enrollment in the study.

4. Participant or participant's parents are known to have phenylketonuria.

5. Participant has participated in an investigational drug or device study within the 30 days prior to study screening.

6. Participant shows evidence of current excessive alcohol consumption or drug dependence.

7. Participant has uncontrolled, clinically significant renal disease manifested by 1.5 * ULN of serum creatinine or blood urea nitrogen (BUN) levels.

8. Participant has calculated creatinine clearance level of <60 mL/min

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Encapsulated Mesalamine Granules (eMG)
eMG capsules will be administered per dose and schedule specified in the arm.

Locations

Country	Name	City	State
United States	AGMG Clinical Research	Anaheim	California
United States	Northwest Gastroenterologists S.C.	Arlington Heights	Illinois
United States	Consultative Gastroenterology	Atlanta	Georgia
United States	Digestive Care Associates	Austell	Georgia
United States	Sinai Medical Office Building	Baltimore	Maryland
United States	Lovelace Scientific Resources	Beverly Hills	California
United States	Birmingham Gastroenterology Associates	Birmingham	Alabama
United States	Connecticut Gastroenterology Institute	Bristol	Connecticut
United States	Clinical Research of Tampa Bay, Inc.	Brooksville	Florida
United States	Charleston Gastroenterology Specialists, LLC	Charleston	South Carolina
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	New River Research Institute	Christiansburg	Virginia
United States	Consultants for Clinical Research, Inc.	Cincinnati	Ohio
United States	Center for Gastroenterology	Decatur	Georgia
United States	First Care Family Doctors South	Fayetteville	Arkansas
United States	Digestive Liver Disease Specialists, Medical Group	Garden Grove	California
United States	LeBauer Research Associates, PA	Greensboro	North Carolina
United States	Medical Research Unlimited	Hialeah	Florida
United States	Bethany Medical Center	High Point	North Carolina
United States	Philip J. Beam Medical Center	Hollywood	Maryland
United States	Southern Clinical Research Consultants	Hollywood	Florida
United States	Clinical Trial Network	Houston	Texas
United States	Houston Digestive Disease Clinic	Houston	Texas
United States	NationsMed Clinical Research	Houston	Texas
United States	Little Rock Diagnostic Clinic	Little Rock	Arkansas
United States	Professionals for Clinical Research	Littleton	Colorado
United States	Long Beach VA Medical Center	Long Beach	California
United States	University of Louisville	Louisville	Kentucky
United States	Gastroenterology Associates of Central Georgia	Macon	Georgia
United States	Center for Digestive & Liver Diseases	Mexico	Missouri
United States	Center for Advanced Research	Milwaukee	Wisconsin
United States	Medical Research Institute	Nashville	Tennessee
United States	United Medical Research	New Smyrna Beach	Florida
United States	Simon Lichtiger, M.D.	New York	New York
United States	Venture Research Institute, LLC	North Miami Beach	Florida
United States	VA Medical Center, Northport	Northport	New York
United States	Shore Health Group	Ocean City	New Jersey
United States	Community Clinical Trials	Orange	California
United States	Penninsula Research, Inc.	Ormond Beach	Florida
United States	Advanced Gastroenterology Associates	Palm Harbor	Florida
United States	Boice-Willis Clinic	Rocky Mount	North Carolina
United States	St. Louis Center for Clinical Research	Saint Louis	Missouri
United States	Rider Research Group	San Francisco	California
United States	John Jolley, M.D.	San Rafael	California
United States	Lovelace Scientific Resources	Santa Ana	California
United States	Santa Barbara Clinical Research	Santa Barbara	California
United States	Advent Clinical Research	Sarasota	Florida
United States	Lovelace Scientific Resources	Sarasota	Florida
United States	Seattle Gastroenterology Associates	Seattle	Washington
United States	Hillcrest Clinical Research, LLC	Simpsonville	South Carolina
United States	Eastern Washington Clinical Research Center	Spokane	Washington
United States	Spokane Digestive Disease Center	Spokane	Washington
United States	VA Medical Center	Syracuse	New York
United States	Digestive Disease Research Center	Tacoma	Washington
United States	Cotton-O'Neil Digestive Health Center	Topeka	Kansas
United States	Upstate Gastroenterology Associates, PC	Troy	New York
United States	Oklahoma Gastroenterology Associates, LLC	Tulsa	Oklahoma
United States	Avamar Center for Endoscopy	Warren	Ohio
United States	Covenant Clinic	Waterloo	Iowa
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any event with a start date occurring on or after treatment Day 1 or, if pre-existing, worsening after treatment Day 1. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.	Baseline (Day 1) up to follow-up (24.5 months)
Primary	Number of Participants Who Prematurely Discontinued Treatment	Number of participants who prematurely discontinued treatment due to any reason were reported.	Baseline up to Month 24
Primary	Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities	Criteria for potentially clinically significant abnormal hematology and blood chemistry values included: hemoglobin (grams/deciliter [g/dL]): <10 and =3 decrease, or >20; hematocrit (%): <30 and =10 decrease, or >60; platelets (*10^9 cells/liter): <100 or >700 (normal: 150-400); white blood cells (*10^9 cells/liter): <2.3 or >16.2 (normal: 3.5-11.1); alanine aminotransferase (units/liter [U/L]): =3 * upper limit of normal (ULN) (normal range 0-47 U/L); aspartate aminotransferase (U/L): =3 * ULN (normal range 0-37 U/L); total bilirubin (micromoles/liter [µmol/L]): >2 times; and calcium creatinine clearance (milliliters/minute [mL/min]): =50.	Baseline up to follow-up (24.5 months)
Primary	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Vital signs included systolic and diastolic blood pressure, pulse rate, body temperature, or body weight.	Baseline, up to follow-up visit (Month 24.5)